Is Nano-Medicine the Future of HIV Treatment?

For the last three decades, scientists have worked to improve and expand the types of antiretroviral drugs on the market that treat people living with HIV. As the years have passed, medications have become more effective, less expensive and widely available in some countries.

But, many regions around the globe still lack access to safe and affordable antiretroviral therapy (ART). A team of researchers from the University of Liverpool in England believes that nanotechnology could help fill that gap.

Andrew Owen, Ph.D., FSB, and Steve Rannard, D.Phil., FRSC, two professors at the University of Liverpool, are leading efforts to use nanotechnology to improve the delivery of HIV drug treatments so that they're more effective and less expensive. The aim of developing solid nanoparticles is to cut the drug dose required for antiretroviral therapy, which brings down cost and ramps up production, Owen told TheBody.com. The research they've conducted over the last eight years has so far proven that nanotechnology can be used to reduce the dosage in half "and still get the same amount of drug exposure within the blood of the patient," said Owen, who teaches molecular and clinical pharmacology. "You can make more drugs and therefore treat more patients."

The two scientists are exploring multiple approaches, but have been most successful with solid drug nanoparticles, which are microscopic objects made from antiretroviral medicine. Earlier this year, the scientists completed two healthy volunteer clinical trials using orally administered nanomedicine. The results, presented at CROI 2017, have shown that oral nanomedicine can be as safe and effective as traditional treatments.

The success of the trials means Owen and Rannard have passed a regulatory hurdle to "take the medicine forward," Owen said. The team is working with a manufacturer to make the oral nanomedicine commercially available, which they hope will happen within the next two to three years. They are also working with the U.S. Food and Drug Administration to develop the drug for the U.S. market. However, their priority is to get the medicine into "resource-limited settings" such as Sub-Saharan Africa and other areas where demand for antiretroviral medicine is "outstripping manufacturing capacity," Owen said.

"We as a species cannot make enough drug to treat all the patients with HIV, so any strategy which reduces the dose required for therapy is a clear win," he added.

Owen and Rannard have received grants from the Engineering and Physical Science Research Council (EPSRC), United States Agency for International Development (USAID), National Institutes for Health (NIH), European Commission and the Clinton Health Access Initiative (CHAI) to support their research.

Another, more-advanced method Owen and Rannard are exploring is long-acting delivery, in which nanoparticles made from a once-daily drug are administered monthly or once every three months via an intramuscular depot injection. "[The approach] is really exciting," Owen said.

Owen and his team are also developing antiretroviral nanomedicine for children. The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that in 2015, 1.8 million children under 15 years old were living with HIV, yet only 49% of these kids had access to antiretroviral medicine. According to Owen, very few of the treatments available to children use child-friendly solutions to administer the drugs.

Many of the antiretroviral medicines given to infants and young kids living with HIV contain an ethanol-based mixture -- essentially "a shot of vodka," said Owen. That exposes children to harmful alcohol-related side effects. One of the "big advantages" of the nanotechnology now in clinical development is that "you can deliver these things in water," Owen told TheBody.com. "You're removing the harsh, unsafe organic solvent, and you're also reducing the dose of the drug which is needed to treat the child."

The treatment they are developing for pediatric use is based on a formulation similar to the one they're prepping for the commercial market. But, the process for children's nanomedicine will take longer because they're using an older drug, Owen told TheBody.com. The project, he said, is "slowed down by the fact that that drug has fallen out of favor as a pediatric medicine," so it's harder to convince funders to provide support.

However, Owen added, the team is trying to "leverage funding from other sources" to move the treatment towards pediatric approval. They are also formulating two new drugs with the same approach through USAID's ART Optimization Programme.

"We're a little bit further behind with those," Owen told TheBody.com, "but our hope is that project completes within the next four years, and then, at that point, we will just be a year or two off [from] taking it to the market if that's successful."